Ad-Tech recalls A-Style SD Depth Electrodes with incorrect MR safety labels. The device may not be safe for MRI use due to missing MR Conditional symbol.
Ad-Tech is recalling these A-Style SD Depth Electrodes because a label discrepancy was identified on A style contact SD electrodes where the MR Conditional symbol was incorrectly placed instead of the MR Unsafe symbol. The A style contacts were not cleared for MR Conditional use. Our records indicate you have received one or more of the affected lots listed above.
Ad-Tech is recalling A-Style Spencer Probe Depth Electrodes because they have the wrong MRI safety label. This could mean the device is unsafe for MRI scans, as it lacks the required MR Conditional symbol.
The electrodes were labeled with an MR Unsafe symbol instead of the required MR Conditional symbol. This means the device was not approved for MRI use, which could lead to unsafe conditions during scans.
Medical professionals using MRI equipment who have the A-Style SD Depth Electrodes with the incorrect label are affected. Those who use these devices for MRI scans are at risk of unsafe conditions.
Look for the model number SD04R-AP58X-000 and lot numbers 170052 or 858859860 on the device. The label shows an MR Unsafe symbol instead of the MR Conditional symbol.
Verify the label shows the MR Conditional symbol instead of MR Unsafe symbol.
Ad-Tech identified a label discrepancy where the MR Conditional symbol was incorrectly placed instead of the MR Unsafe symbol on A-Style SD Depth Electrodes.
The device may not be safe for MRI use, as it lacks the required MR Conditional symbol and was not cleared for MRI applications.
Check for model number SD04R-AP58X-000 and lot numbers 170052 or 858859860 with the MR Unsafe symbol on the label.
We’ve drafted a message you can send Ad-Tech to request your refund or repair — edit it as you like.
Subject: Recall Z-0219-2025 — Ad-Tech Ad-Tech Hello, I own a Ad-Tech that is covered by recall Z-0219-2025 from Ad-Tech. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.